- Rockville, MD
Site Name: USA - Maryland - Rockville
Posted Date: Jun 2 2020
This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following:
Possesses expertise and functional knowledge of the following areas and ability to perform the activity without guidance and producing quality results:
- Preparation, cleaning, sterilization, batching, pasteurization or filtration and delivery of media and solutions for cell culture and purification operations.
- Perform the set-up, operation, cleaning and break-down of process equipment.
- Perform sampling procedures on various analytical instruments to analyze cell culture, solution and/or product concentration characteristics. Operate Filter integrity devices to confirm the integrity of filters pre and post use.
- Set-up of fixed and mobile process equipment and parts with CIP skids to carry out validated cleaning and sterilization processes.
- Develop and follow appropriate standard operating procedures (SOPs), protocols and batch records to safely perform process operations and document compliantly with good documentation and data integrity practices.
- Review all appropriate production documentation and insure GMP compliance and metric attainment.
- Knowledge and skill required to manage and use automation and emerging digital platforms.
- Knowledge of biopharmaceutical processes and equipment to facilitate transfer of processes into Manufacturing, data analysis and identification and escalation of problems to the appropriate support group.
- Lead in the application of the GSK Production System (GPS) continuous improvement system and apply the GPS mindsets and behaviors in problem solving.
- Knowledge and experience with process operations, equipment and instrument monitoring and trending to enable proactive identification of issues to escalate and correct with applicable departments.
- Ability to design tests and establish documentary evidence demonstrating that a procedure, process, or activity carried out in testing and then production maintains the desired level of compliance at all stages. The collection and evaluation of data, from the process design stage throughout production, which establishes scientific evidence that a process is capable of consistently delivering quality products.
- Knowledge and application of standard ERP processes in M-ERP following global and local procedures.
- Comprehensive review of an organization or departments adherence to regulatory guidelines and global corporate and local procedures.
- A key management capability for mid to upper level management that encompasses the ability to collaborate and build relationships to define the organizational and business big picture (mission, vision, strategic plan, etc.), anticipate the future and external environment (competition, market, demand, etc.) and take strategic action to establish a competitive edge and organizational success
- Working with others to gain win-win situations, using persuasive communication, understanding influencing models, negotiation, overcoming resistance.
- Ability to choose a type of communication that is most effective in a given situation.Such competency empowers individuals to achieve the goals of any communication in a manner that is best suited for all parties involved.
- The ability to provide strong teaching and facilitation skills in training delivery to engage an audience to ensure that high impact learning outcomes are reached.
- Ability to articulate production equipment and / or manufacturing process problems to ensure accurate and detailed communication.
- Transfers information to audiences of varying levels of technical knowledge, so that each member of the audience clearly understands the message.
- Follow all related safety policies and procedures and put safety first by playing an active role in identifying and correcting unsafe behaviors and conditions.
Basic understanding and knowledge of the following areas and ability to perform the activity with some supervisory guidance:
- An appreciation of cultural differences and diversity in the workplace.
- Build positive relationships with others and conduct negotiation to establish win/win solutions.
- Developing team capability to learn with knowledge of coaching styles, listening and questioning techniques, feedback models and emotional intelligence.
- Recruit, hire and maintain appropriate staff levels to meet operational and strategic goals
- Ability to explain and utilize techniques to improve and sustain physical energy levels through the day to support resilience on teams.
We are looking for professionals with these required skills to achieve our goals:
- High School Diploma or equivalency
- 5+ years of directly related experience manufacturing experience in the pharmaceutical or biotechnology industry, with the demonstration of a high level of performance and 2 years of leadership experience
- Understanding the of the basic Federal Drug Administration (FDA) and current Good Manufacturing Practices (cGMP) regulations; Must exhibit GSK Values and Expectations
- Follow detailed processing instructions as well as accurately documenting any necessary information
- Work shifts that cover a 24/7 production operation
- Lift and carry materials up to 50 lbs
If you have the following characteristics, it would be a plus:
- Bachelor of Science / Bachelor of Art / Associates Degree in biological sciences, chemical sciences, engineering or equivalent technical discipline
- Strong verbal and written skills
- Demonstrated ability to work effectively in a team
Our values and expectations are at the heart of everything we do and form an important part of our culture. These include Patient focus, Transparency, Respect, Integrity along with Courage, Accountability, Development, and Teamwork. As GSK focuses on our values and expectations and a culture of innovation, performance, and trust, the successful candidate will demonstrate the following capabilities:
- Agile and distributed decision-making - using evidence and applying judgement to balance pace, rigor and risk, governance and control, managing ambiguity and paradox.
- Managing individual performance.
- Creating a performance culture and driving results, prioritization, execution, delivering performance.
- Setting strategic direction and leading on-going organizational transformation.
- Building a resilient organization.
- Building strong relationships and collaboration in service of common goals, engaging the organization and building trusted external networks for mutual benefit.
- Managing P&L and capital allocation.
If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at 1-877-694-7547 (US Toll Free) or +1 801 567 5155 (outside US).
GSK is an Equal Opportunity Employer and, in the US, we adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class.
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